BEUDAMED
    FDA Enforcement Class II Terminated

    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

    Recall: Z-1234-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1234-2014
    Event ID
    67584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Information Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    March 26, 2014
    Initiation Date
    February 21, 2014
    Classification Date
    March 19, 2014
    Termination Date
    November 12, 2015
    Address
    7 Blue Hill River Rd, Canton, MA, 02021-1001, United States

    Description

    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).

    Reason

    Potential for erroneous result reporting.

    Code Info

    Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.

    Distribution

    Distributed USA (nationwide) and Canada.

    Quantity

    438